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Steris

21 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Prolystica Pass Thru Disinfectant Wipes (DEN240075)Steris2026-05-01
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K251452)Steris2025-06-06
Electro Lube NXT (K242773)Steris2025-04-15
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (DEN230085)Steris2024-11-12
CELERITY HP Indicator Tape (PCC077) (K242189)Steris2024-08-20
MetriCide™ OPA Plus Solution Test Strip (K241344)Steris2024-06-11
Electro Lube NXT (K241055)Steris2024-05-31
CELERITY HP Indicator Tape (K240760)Steris2024-04-10
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) (K232826)Steris2024-03-08
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (K233654)Steris2023-12-08
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) (K233187)Steris2023-10-27
V-PRO maX 2 Low Temperature Sterilization System (K233065)Steris2023-10-20
BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) (K232951)Steris2023-10-20
AMSCO 600 Steam Sterilizer (K232485)Steris2023-09-13
Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (K231488)Steris2023-08-07
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849)Steris2022-09-30
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (K222440)Steris2022-09-09
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (K222093)Steris2022-09-09
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222543)Steris2022-08-25
CELERITY 20 HP Challenge Pack (K220473)Steris2022-03-18
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K203223)Steris2021-01-28

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Every clearance here is in the API, with alerts when new ones post.